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NCT03463265 · ClinicalTrials.gov registry record · Phase 2
Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
A Phase 2 study of High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma, sponsored by Aadi Bioscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 3
- Study locations
NCT03463265: Completed Phase 2 study of High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma, sponsored by Aadi Bioscience.
NCT03463265 is a Phase 2 study of High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma that has completed, run by Aadi Bioscience. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03463265, a Phase 2 study of High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma, has completed, sponsored by Aadi Bioscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 3
- Study locations
Study Summary
Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.
Primary Outcome
Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology \[RANO\]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.
Conditions Studied
Interventions
- DRUG nab-sirolimus
- DRUG nab-sirolimus + temozolomide
- DRUG nab-sirolimus + bevacizumab
- DRUG nab-sirolimus + lomustine
- DRUG nab-sirolimus + marizomib (MRZ)
Study Locations (3)
California
- St. Joseph Heritage Healthcare - Fullerton
- Hoag Memorial Hospital Presbyterian - Newport Beach
- John Wayne Cancer Institute - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2022-08-26 |
| Phase | Phase 2 |
What the finished NCT03463265 record still lists
NCT03463265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which nab-sirolimus is the first listed.
NCT03463265 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03463265 about?
NCT03463265 is a clinical study titled "Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma". Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.
What is the current status of trial NCT03463265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2018-08-01. Estimated completion is 2022-08-26.
What conditions does trial NCT03463265 study?
This clinical trial studies the following conditions: High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma.
What interventions are being tested in trial NCT03463265?
The interventions under investigation include: nab-sirolimus (DRUG), nab-sirolimus + temozolomide (DRUG), nab-sirolimus + bevacizumab (DRUG), nab-sirolimus + lomustine (DRUG), nab-sirolimus + marizomib (MRZ) (DRUG).
Who is sponsoring clinical trial NCT03463265?
This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03463265 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03463265's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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